MagForce Nanotechnologies AG has received certification according to European Norm (EN) ISO 13485:2003 + AC:2007. As part of its audit, Medcert GmbH, the medical certification and testing company, examined the quality management systems of MagForce in the areas of development, manufacturing, final inspection and distribution for the products used for its therapy systems for hyperthermia and thermoablation, including the related treatment planning software, and determined that all requirements of the ISO standard were properly fulfilled. Once the CE conformity assessment procedures have been completed for all components, this certification will mark a final key step toward the successful commercialization of the company’s Nano-Cancer® therapy.
"We are extremely pleased to have received this latest certification, which now also confirms that the development areas for our NanoTherm® and NanoPlan® products, audited for the first time, likewise fulfill the requirements for a rigorous quality management system. This represents another key step on the road toward the European market launch of our novel cancer treatment approach," said Dr. Uwe Maschek, CEO of MagForce Nanotechnologies AG.
MagForce Nanotechnologies AG is the world’s leading company in the area of nanotechnology-based cancer treatment. Its patented Nano-Cancer® therapy allows the targeted destruction of tumors using superparamagnetic nanoparticles to generate heat. The nanotechnology from MagForce represents a revolutionary approach to the future successful treatment of solid tumors.